Long-Term Safety, Efficacy Data Released for Hysingla ER

PALM SPRINGS, Calif. — Officials with Purdue are announcing data from a long-term safety and efficacy study of hydrocodone bitartrate extended-release (Hysingla ER)) tablets with abuse-deterrent properties, at the 34th Annual American Pain Society Scientific Meeting being held this week here.

The open-label study with a 76-week maintenance period evaluated the safety and effectiveness and other outcomes of the tablets in 106 opioid-naive and opioid-experienced patients with moderate-to-severe chronic pain.

Treatment with hydrocodone bitartrate extendred-release led to improvements in and maintenance of chronic pain relief without the need for dose increase.

The most common treatment-emergent adverse events were constipation, nausea, upper respiratory tract infection, and fatigue. No cases of abuse or diversion of study drug were reported, and no safety concerns were raised from various audiologic, clinical laboratory, and ECG assessments, company officials reported.